510(k) Report

Devices descending from K070818

14 later devices reach MEDILOGAR4, MEDILOGAR12 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253562medilogFDSchiller AG20260—
+1K083820Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-CVasomedical, Inc.200912—
+2K111180Vasomedical-Biox 12- Channel Ambulatory Ecg Holter Recorder Model 1304, Vasomedical-Biox…Vasomedical, Inc.20110—
+2K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix20106—
+2K092785Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software…Vasomedical, Inc.20103—
+3K231104ABPMproSomnomedics GmbH20230—
+3K110525Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd.20115—
+3K111096Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood Pressure Recorder Model…Vasomedical, Inc.20111—
+4K253293VitaloJAK Clinic (Model 7100)Vitalograph, Ltd.20250—
+4K230184Holter ECG and ABP SystemEdan Instruments, Inc.20230—
+4K201077Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs20203—
+5K220893Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc.20222—
+6K223382AeviceMDAevice Health Pte., Ltd.20231—
+7K243603AeviceMDAevice Health Pte., Ltd.20250—